Pulmonary And Renal Support During Acute Respiratory Distress Syndrome (PARSA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01239966|
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : February 23, 2016
In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.
Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.
The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.
For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome Acute Renal Failure||Device: Combined ECCOR and RRT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||June 2015|
- Device: Combined ECCOR and RRT
Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.
- Arterial carbon dioxide reduction [ Time Frame: 20 min ]20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
- Gas transfer measurement [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of PO2 and PCO2 before and after the membrane oxygenation
- Arterial blood gases [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of arterial blood gases
- carbon dioxide elimination (VCO2) [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator
- Respiratory mechanics and hemodynamic parameters [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]Measurement of respiratory mechanics and hemodynamic parameters
- Safety monitoring [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
Continuous measurement of the differential pressure across the oxygenator membrane and across the hemofilter.
Assessment of catheter dysfunction, clotting or disruption of the extra-corporeal circuit, clotting of the oxygenator membrane or of the hemofilter.
Assessment of patient's haemorragic or thrombotic complications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239966
|Hopital Paul Desbief|
|Marseille, France, 13002|
|Hopital Ambroise Pare|
|Marseille, France, 13006|
|Principal Investigator:||Jérôme Allardet-Servent, MD||Hopital Ambroise Pare|